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IRCT20230813059137N1 IRCT 2023-08-28 “Victor Babes” University of Medicine and Pharmacy Timisoara, Romania Comparison of exercise program and foot orthoses versus exercise program in patients after tibial pilon fracture surgery Comparison of the effects of foot orthoses and exercise program in improving gait, balance and ankle muscle properties in patients after tibial pilon fracture surgery 2023-10-01 anticipated 36 Complete https://irct.ir/trial/72125 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Randomization will be performed directly after baseline assessment by a researcher who was not involved in the recruitment of participants using a computer-generated random sequence table. The participants will be randomized into 2 groups at a proportion of 1:1 with 18 patients allocated into each group (Group 1: patients who use foot orthoses and follow rehabilitation program, Groupt 2: patients who follow the rehabilitation program only). Because of the nature of the interventions, it will be impossible to blind the therapists and patients involved in the study. 3 Condition 1: Fracture of lower end of tibia. Condition 2: Other abnormalities of gait and mobility. Intervention 1: Intervention group 1: that will wear foot orthoses in addition to physical exercise. Intervention 2: Intervention group 2: will only perform physical exercise training. Yes - There is a plan to make this available What will be shared: The data, representing information about the subjects (baseline, age, gender, height, weight, an-amnestic data), as well as the results of the assessments, will be kept and stored within the De-partment of Rehabilitation, Physical Medicine and Rheumatology of the “Victor Babes” University of Medicine and Pharmacy Timisoara. The results of the study will be disseminated through the publication of articles in peer-reviewed journals, ensuring the confidentiality of the subjects (no publication of subjects' personal data, photographs or video recordings). Essential documents (subject data, evaluation results) must remain complete and legible throughout the data retention period. The data retention period is 10 years from the end of the study. When: The data will become available at the end of the study. The data retention period is 10 years from the end of the study. To whom: The data is available only for people working in academic institutions and only for research purposes. Conditions: The data can be used only for research purposes. Where to obtain: The data/documents are obtainable from the Department of Rehabilitation, Physical Medicine and Rheumatology of the “Victor Babes” University of Medicine and Pharmacy Timisoara. How to obtain: To obtain data access approval for research or health service assessment projects, requestors must complete our Data Access Request Form and submit supporting documentation (i.e., project proposal, research ethics board submission (if applicable), CV, etc.).. A Data Access Request may be made by one of the following methods: email, fax, mail or at the secretary of the department. Comments:
public Andrei-Daniel Bolovan
no. 2 Eftimie Murgu Square, Timisoara
Timisoara Romania 300041 +40 256 204 250 andrei.bolovan@umft.ro "Victor Babes” University of Medicine and Pharmacy Timisoara, Romania scientific Andrei-Daniel Bolovan
no. 2 Eftimie Murgu Square, Timisoara
Timisoara Romania 300041 000256204250 andrei.bolovan@umft.ro “Victor Babes” University of Medicine and Pharmacy Timisoara, Romania Romania patients must be adults who have undergone surgery for unilateral tibial pilon fracture; must show clinical and radiological evidence of fracture healing; must be able to put full weight on the fractured leg;; must agree to participate voluntarily healthy contralateral lower leg that can be used as a healthy control; 18 years no limit Both history of traumas or fractures in the lower leg with the tibial pilon fracture; a history of traumas or fractures in the opposite lower leg used as healthy control any neurological or other health conditions that may cause difficulty in walking or changes in muscle function lower leg asymmetry not related to the tibial pilon fracture psychiatric disorders or other disorders that affect compliance S82.3 R26.8 Fracture of lower end of tibia Other abnormalities of gait and mobility Treatment - Devices Rehabilitation Intervention group 1: that will wear foot orthoses in addition to physical exercise Intervention group 2: will only perform physical exercise training. The primary outcomes will be gait, balance, calf muscle properties and muscle strenght. Timepoint: The evaluation of the primary outcome following the application of intervention is after 3 months. Method of measurement: The assessment involves four different testing procedures: myotonometry, muscle strength testing, gait analysis, and double-leg and single-leg balance tests. The secondary outcomes will be the quality of life and the severity of pain during sports and daily activities. Timepoint: Secondary outcome will be measured 3 months after the application of intervention. Method of measurement: Assessment questionnaires such as Olerud-Molander Ankle Score ( OMAS) and visual analogue scale (VAS) will be used. “Victor Babes” University of Medicine and Pharmacy Timisoara, Romania Approved 2023-08-25 Ethics Committee of the Victor Babes University of Medicine and Pharmacy Timisoara Eftimie Murgu Square, No. 2 Timisoara Timis Romania